Nuevas normas armonizadas conforme al MDR y al IVDR

    On 30 January 2026, the Official Journal of the European Union published Commission Implementing Decision (EU) 2026/193 and (EU) 2026/197, introducing updates to harmonised standards supporting the MDR and IVDR.

    These updates follow a European Commission request to CEN and CENELEC to reassess existing standards, originally developed under the Directives, to ensure alignment with the MDR and IVDR framework and current state of the art.

    Key updates

    MDR – updated and newly harmonised standards - Implementing Decision (EU) 2026/193 amends Decision (EU) 2021/1182 with new and revised standards, including:

    Implants and surgical devices:

    • EN ISO 7197:2024 (neurosurgical implants)
    • EN ISO 14630:2024 (general requirements for non-active surgical implants)
    • EN ISO 21535:2024 and EN ISO 21536:2024 (joint replacement implants)

    Sterilisation:

    • EN ISO 17665:2024

    Biocompatibility (breathing gas pathways):

    • EN ISO 18562 series (parts 1–4:2024)

    Connectors for liquids and gases:

    • EN ISO 80369-2:2024

    Amendments to key standards:

    • EN ISO 10993-4:2017/A1:2025 (biological evaluation)
    • EN ISO 14155:2020/A11:2024 (clinical investigation)

    IVDR – newly harmonised standards - Implementing Decision (EU) 2026/197 amends Decision (EU) 2021/1195, including:

    Sterilisation:

    • EN ISO 17665:2024

    Labelling and information supplied by the manufacturer:

    • EN ISO 18113 series (parts 1–5:2024)

    These updates ensure that harmonised standards reflect the latest scientific and technical progress and remain aligned with MDR/IVDR requirements.

    By applying these standards, manufacturers can continue to benefit from the presumption of conformity with applicable General Safety and Performance Requirements (GSPRs), making them a key tool for demonstrating compliance.

    What does this mean for you?

    Manufacturers should review whether the new or updated standards apply to their devices and assess the impact on design, testing, clinical evaluation, and labelling.

    Technical documentation and ongoing projects should be updated where needed to reflect the latest versions of harmonised standards.